The sentence of sentence against the defendant shall be suspended.

Punishment of the crime

The Defendant is an employee of a school foundation D D D Private Teaching Institute E University D D D D D D D D D D D D D D D D D D D D D

Any person who intends to conduct a clinical trial with a medical device shall prepare a clinical trial plan and obtain approval from the Minister of Food and Drug Safety, and shall not use any medical device approved for the clinical trial.

Nevertheless, on April 26, 2016, the Defendant conducted a clinical trial by taking advantage of the 'Medical Devices (Class 1, J, and K) for the purpose of taking the subjects and M, without obtaining approval from the Director of the Food and Drug Safety Department,’ which is a research task of the Ministry of Health and Welfare in the year 2015, the Defendant entered into an entrustment contract with the I University Hospital, which is a research task of the Ministry of Health and Welfare, and taking advantage of the 'Medical Devices (Class 1, J, and K)’, which is a medical device provided by the participating enterprise, while conducting the clinical trial.

Summary of Evidence

1. The defendant's legal statement (as at the tenth public trial date);

1. Statement by the witnessN in the third public trial records;

1. Management of health and medical research and development projects - a copy of an agreement on entrustment of health and medical services and a request for research expenses, a copy of the research and development task agreement, a copy of the research plan, a copy of the notification of the results of deliberation on the research plan, matters permitted to manufacture medical image processing devices, specifications of transactions, such as oral camera, data on conducting clinical trials, and application of Acts and subordinate statutes of the research report;

1. Relevant legal provisions and Articles 55, 52(1)1, and 26(6) of the former Medical Devices Act (Amended by Act No. 1430, Dec. 2, 2016);

1. Penalty fine of 500,000 won to be suspended;

1. Articles 70(1) and 69(2) of the Criminal Act (100,000 won per day) of the Criminal Act to attract a workhouse;

1. Article 59(1) of the Criminal Act of the suspended sentence (the criminal defendant is divided and reflected in the crime, the criminal defendant is a primary offender who has no record of criminal punishment, and the clinical trial of this case is supervised.